Ondansetron Disintegrating Oral Tablet

Brand(s)
Zofran
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-10-01)
Oldest Current Product
1999-03-01
License(s)
NDA, ANDA
RxNORM
DISINTEGRATING ORAL TABLET\ONDANSETRON
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\ONDANSETRON
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\ONDANSETRON
ORAL\TABLET, ORALLY DISINTEGRATING\ONDANSETRON HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\ONDANSETRON

product(s) by strength(s)

ondansetron 4 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730569ZofranNDAGlaxosmithkline Llc1999-03-01ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGNDA020781c7d61d98-fe86-4340-9b86-47eb92acaa0e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787732ANDAMylan Pharmaceuticals Inc.2012-09-10ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA078139aa5cd244-dbd5-4cd6-a9f6-e045405ae519
2007815238ANDASandoz Inc2007-08-31ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA0780505fad6aba-321a-4ed3-8d8e-2806aaeb2ff7
3572370077ANDACitron Pharma Llc2010-04-12ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA090469eb74425c-c635-4d99-8e98-e63e7359fb89
4627560240ANDASun Pharmaceutical Industries Limited2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA07755752dc6871-47d3-11dc-99cc-f742b487c00e
5633040346ANDARnabaxy Pharmaceuticals Inc.2012-01-10ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA07860269017f9f-1815-46d2-8e40-71cad10fa9d1
6658620390ANDAAurobindo Pharma Limited2010-04-12ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA090469cab63f24-8728-4927-aba5-53e8d2e44cdb
7680010246ANDABluepoint Laboratories2014-03-13ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA078152ed1132ec-c2cd-4646-b69d-26663bb937a4
8684620157ANDAGlenmark Generics Inc., Usa2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA078152eee5217a-eba8-463a-812d-bf3c66f0934f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900545ANDAStat Rx Usa Llc2009-10-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA0781525e2dbda9-aceb-4bfb-9c3f-e7b6118f580c
2332610747ANDAAidarex Pharmaceuticals Llc2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA078152366b4f74-02aa-4f67-a7cb-7362e60e1052
3333580498ANDARxchange Co.2014-11-26ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620390ANDA090469aba318b2-e2b8-4fae-a58d-ac0b25552195
4353560197ANDALake Erie Medical Dba Quality Care Products Llc2010-11-10ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA077557d497e5be-846f-498c-ba52-b58fffa08b20
5353560678ANDALake Erie Medical Dba Quality Care Products Llc2011-07-26ONDANSETRONORALTABLET, ORALLY DISINTEGRATING003787732ANDA078139482162fc-1ea6-4012-ae59-76911a047821
6353560755ANDALake Erie Medical Dba Quality Care Products Llc2007-08-31ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815238ANDA07805091eddc2b-50d6-4f5b-8916-62525fbdc375
7422540077ANDARebel Distributors Corp2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA0775576c450150-a7a4-46f3-b62a-848eeefada06
8422540213ANDARebel Distributors Corp2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA078152a9fdc04a-b4e5-4eed-be1f-8a629dc447be
9430630052ANDAPd-Rx Pharmaceuticals, Inc.2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA077557a67eaa4d-7aa4-4a55-9198-62a51261c2ef
10430630247ANDAPd-Rx Pharmaceuticals, Inc.2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA077557dfa2dfa8-26b2-4623-8dab-af9e9f32320f
11430630560ANDAPd-Rx Pharmaceuticals, Inc.2007-08-31ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815238ANDA0780509569dacb-b54d-4955-a43f-8fec30c777c4
12458650598ANDAMedsource Pharmaceuticals2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA0781521edf01f7-8cc1-6616-e054-00144ff88e88
13504360133ANDAUnit Dose Services2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA0775578d763a30-c778-4560-82a0-91e7b99c8e85
14521250268ANDARemedyrepack Inc.2013-05-06, 2013-06-10, 2015-08-25ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA07755710641ef4-0fc9-4b24-9e43-7d06404989bb, 794a1ebe-399c-4ecb-94c0-507b6cc59b5d, c8e90bca-6ef8-4177-810c-927c0abd32e4
15521250568ANDARemedyrepack Inc.2013-06-10, 2013-06-24, 2014-03-24, 2014-11-04ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA0781525c767c0e-9cac-4286-ab93-dece45f146ce, 6c085fdb-1e64-427d-9c01-5933de94a320, 9a503ba6-1a63-4059-ace3-40244d43c8f7, e5950fac-27c8-49b8-81d5-046ec065621b
16548685887ANDAPhysicians Total Care, Inc.2008-05-08ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815238ANDA078050ca09dd2c-02ed-4d26-af3c-aaff4120887e
17550453848ANDADispensing Solutions, Inc.2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA078152e5e8353f-4e4c-4036-9376-2ac205d13b14
18551543680ANDACardinal Health2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA0781523c34ca82-9705-4784-be7c-8b50351d14fc
19551544567ANDACardinal Health2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA07755726aff90c-49ea-46ac-bbf3-c188c2b061c9
20551545431ANDACardinal Health2007-08-31ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815238ANDA0780507eed9b3a-207f-49ca-83cd-8172357363d3
21552890559ANDAPd-Rx Pharmaceuticals, Inc.2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA077557bd365c0e-7f76-4904-8f21-bed9ec2d0360
22581180240ANDAClinical Solutions Wholesale2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560240ANDA077557a4d7f7d0-b073-463a-83af-9587ac10c943
23581186666ANDAClinical Solutions Wholesale2007-08-31ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815238ANDA07805028e95ab0-1a7f-40dd-af0e-e54378ca06f6
24607600305ANDASt Marys Medical Park Pharmacy2014-05-23ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620390ANDA09046963aabd84-6767-470b-bfe1-077dee835897
25617860095ANDARemedyrepack Inc.2014-11-13, 2015-01-12ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620390ANDA0904696a49ae10-f64d-4297-b82a-99642b583f93, bb535ce1-0b32-449f-8093-789f9d83b96a
26619190545ANDADirect Rx2014-01-01ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620390ANDA090469d4868404-0515-447b-8b01-81c0478de28c
27631870002ANDAProficient Rx Lp2007-08-31ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815238ANDA078050bf2b41aa-8bac-4de7-98b2-884cbcee6c6c
28631870256ANDAProficient Rx Lp2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA07815281366c85-c6c9-4a9a-9fe5-cdd8c2d19f74
29631870526ANDAProficient Rx Lp2010-04-12ONDANSETRONORALTABLET, ORALLY DISINTEGRATING572370077ANDA090469f6f2e4ee-dc8b-478d-b0d6-d192119691b7
30636294014ANDABryant Ranch Prepack2007-06-27ONDANSETRON HYDROCHLORIDEORALTABLET, ORALLY DISINTEGRATING684620157ANDA078152267abdd4-02f8-c04d-d009-d838f7e0a905
31682587068ANDADispensing Solutions, Inc.2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA07815236c80e18-671c-4612-a8e7-07962bb102e0
32687889329ANDAPreferred Pharmaceuticals, Inc.2015-03-31ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620157ANDA078152340f1a87-0bc6-46bf-8f16-80a5348ad15f
33687889670ANDAPreferred Pharmaceuticals, Inc.2013-07-24ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620390ANDA0904694b6ef4cb-4993-494a-bf52-901e545d1a81

ondansetron 8 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730570ZofranNDAGlaxosmithkline Llc1999-03-01ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGNDA020781c7d61d98-fe86-4340-9b86-47eb92acaa0e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787734ANDAMylan Pharmaceuticals Inc.2012-09-10ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA078139aa5cd244-dbd5-4cd6-a9f6-e045405ae519
2007815239ANDASandoz Inc2007-08-13ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA0780505fad6aba-321a-4ed3-8d8e-2806aaeb2ff7
3572370078ANDACitron Pharma Llc2010-04-12ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA090469eb74425c-c635-4d99-8e98-e63e7359fb89
4627560356ANDASun Pharmaceutical Industries Limited2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA07755752dc6871-47d3-11dc-99cc-f742b487c00e
5633040347ANDARnabaxy Pharmaceuticals Inc.2012-01-10ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA07860269017f9f-1815-46d2-8e40-71cad10fa9d1
6658620391ANDAAurobindo Pharma Limited2010-04-12ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA090469cab63f24-8728-4927-aba5-53e8d2e44cdb
7680010247ANDABluepoint Laboratories2014-03-13ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA078152ed1132ec-c2cd-4646-b69d-26663bb937a4
8684620158ANDAGlenmark Generics Inc., Usa2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATINGANDA078152eee5217a-eba8-463a-812d-bf3c66f0934f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1118190365ANDAHhs/Program Support Center/Supply Service Center2011-07-26ONDANSETRONORALTABLET, ORALLY DISINTEGRATING003787734ANDA07813916ed3ca8-c85c-4d06-9c4f-d5bbf344b12e
2216950380ANDARebel Distributors Corp2007-08-13ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815239ANDA0780500934b7ad-41c4-418d-86e3-a2ea4e7bb4c7
3332610761ANDAAidarex Pharmaceuticals Llc2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620158ANDA078152366b4f74-02aa-4f67-a7cb-7362e60e1052
4333580512ANDARxchange Co.2014-12-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620391ANDA0904690e62c438-359f-4cec-a785-9c7ac09fa6f8
5422540097ANDARebel Distributors Corp2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560356ANDA0775576c450150-a7a4-46f3-b62a-848eeefada06
6422540212ANDARebel Distributors Corp2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620158ANDA078152c286dba1-e6b1-4cf0-936d-9af42d8eedc3
7430630273ANDAPd-Rx Pharmaceuticals, Inc.2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620158ANDA078152d117de5f-64e5-464c-b782-de0f07e66c8e
8430630592ANDAPd-Rx Pharmaceuticals, Inc.2007-08-13ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815239ANDA078050a02eae38-c045-40bb-a5b2-4813165f6a09
9458650563ANDAMedsource Pharmaceuticals2010-04-12ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620391ANDA0904691eb89f6e-6e01-5812-e054-00144ff88e88
10493490858ZofranNDARemedyrepack Inc.2011-12-19ONDANSETRON HYDROCHLORIDEORALTABLET, ORALLY DISINTEGRATING001730570NDA020781ff8d38d7-3f94-4f4c-89ec-58265add8437
11521250569ANDARemedyrepack Inc.2013-05-23, 2013-08-21, 2014-10-14, 2014-10-29ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560356ANDA0775570defd6c7-c493-4230-9e09-cc3784e480e2, 192fb07a-e8b0-4f91-9882-6d456377cc98, a1f0a439-c5f3-4025-8637-a957eab4d2db, f3483b32-344c-4097-bd2b-56545edd0ce5
12548685749ANDAPhysicians Total Care, Inc.2007-01-16ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815239ANDA078050ca09dd2c-02ed-4d26-af3c-aaff4120887e
13551543683ANDACardinal Health2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620158ANDA0781522e6db6ab-02c1-434c-b996-e8821ba03beb
14581180356ANDAClinical Solutions Wholesale2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560356ANDA077557a4d7f7d0-b073-463a-83af-9587ac10c943
15617860191ANDARemedyrepack Inc.2015-02-26ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815239ANDA07805063bfdd45-a09a-49c6-8776-10b64e0b2430
16619190218ANDADirect Rx2014-01-01ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815239ANDA07805014752e63-c7a7-4400-825b-ddab1ab9e782
17619190986ANDADirect Rx2014-01-01ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620391ANDA090469b38feff2-900a-4e0c-8260-8f090edbc0bc
18631870199ANDAProficient Rx Lp2007-06-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620158ANDA07815281366c85-c6c9-4a9a-9fe5-cdd8c2d19f74
19631870266ANDAProficient Rx Lp2010-04-12ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620391ANDA090469f1191e52-982e-49d1-946e-01b469ccedfe
20631870483ANDAProficient Rx Lp2007-08-13ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815239ANDA078050bf2b41aa-8bac-4de7-98b2-884cbcee6c6c
21636294306ANDABryant Ranch Prepack2007-08-02ONDANSETRONORALTABLET, ORALLY DISINTEGRATING627560356ANDA077557384a5cfb-05dd-2b79-73f4-a01a47a9eb3e
22687888937ANDAPreferred Pharmaceuticals, Inc.2015-10-16ONDANSETRONORALTABLET, ORALLY DISINTEGRATING007815239ANDA07805054d91a9e-44d8-4201-a82d-fe948a766808
23687889559ANDAPreferred Pharmaceuticals, Inc.2013-08-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING658620391ANDA090469b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da
24687889770ANDAPreferred Pharmaceuticals, Inc.2012-07-27ONDANSETRONORALTABLET, ORALLY DISINTEGRATING684620158ANDA078152340f1a87-0bc6-46bf-8f16-80a5348ad15f

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA076506ONDANSETRONTruePAR PHARMACEUTICAL INC2006-12-26ANDA076506_001, ANDA076506_002Ondansetron Oral Tablet
2ANDA076693ONDANSETRONBARR LABORATORIES INC2007-06-25ANDA076693_001, ANDA076693_002Ondansetron Oral Tablet
3ANDA076810ONDANSETRONTEVA PHARMACEUTICALS USA INC2007-06-25ANDA076810_001, ANDA076810_002Ondansetron Oral Tablet
4ANDA077406ONDANSETRONTruePAR PHARMACEUTICAL INC2006-12-26ANDA077406_001, ANDA077406_002Ondansetron Oral Tablet
5ANDA077557ONDANSETRONSUN PHARMACEUTICAL INDUSTRIES LTD2007-08-02ANDA077557_001, ANDA077557_002Ondansetron Oral Tablet
6ANDA077717ONDANSETRONTrueNESHER PHARMACEUTICALS USA LLC2007-06-25ANDA077717_001, ANDA077717_002Ondansetron Oral Tablet
7ANDA078050ONDANSETRONSANDOZ INC2007-08-13ANDA078050_001, ANDA078050_002Ondansetron Oral Tablet
8ANDA078139ONDANSETRONMYLAN PHARMACEUTICALS INC2007-06-25ANDA078139_001, ANDA078139_002Ondansetron Oral Tablet
9ANDA078152ONDANSETRONGLENMARK GENERICS LTD2007-06-27ANDA078152_001, ANDA078152_002Ondansetron Oral Tablet
10ANDA078602ONDANSETRONSUN PHARMACEUTICAL INDUSTRIES LTD2011-02-24ANDA078602_001, ANDA078602_002Ondansetron Oral Tablet
11ANDA090469ONDANSETRONAUROBINDO PHARMA LTD2010-04-12ANDA090469_001, ANDA090469_002Ondansetron Oral Tablet
12NDA020781ZOFRAN ODTNOVARTIS PHARMACEUTICALS CORP1999-01-27p5955488
p6063802
NDA020781_001, NDA020781_002Ondansetron Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076506_001discontinuedONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2006-12-26ONDANSETRON
2ANDA076506_002discontinuedONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2006-12-26ONDANSETRON
3ANDA076693_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-06-25ONDANSETRON
4ANDA076693_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-06-25ONDANSETRON
5ANDA076810_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-06-25ONDANSETRON
6ANDA076810_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-06-25ONDANSETRON
7ANDA077406_001discontinuedONDANSETRON (16MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2006-12-26ONDANSETRON
8ANDA077406_002discontinuedONDANSETRON (24MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2006-12-26ONDANSETRON
9ANDA077557_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-08-02ONDANSETRON
10ANDA077557_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-08-02ONDANSETRON
11ANDA077717_001discontinuedONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2007-06-25ONDANSETRON
12ANDA077717_002discontinuedONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2007-06-25ONDANSETRON
13ANDA078050_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-08-13ONDANSETRON
14ANDA078050_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-08-13ONDANSETRON
15ANDA078139_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-06-25ONDANSETRON
16ANDA078139_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-06-25ONDANSETRON
17ANDA078152_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-06-27ONDANSETRON
18ANDA078152_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2007-06-27ONDANSETRON
19ANDA078602_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-02-24ONDANSETRON
20ANDA078602_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2011-02-24ONDANSETRON
21ANDA090469_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2010-04-12ONDANSETRON
22ANDA090469_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB2010-04-12ONDANSETRON
23NDA020781_001RXONDANSETRON (4MG)ORALTABLET, ORALLY DISINTEGRATINGFalseAB1999-01-27ZOFRAN ODT
24NDA020781_002RXONDANSETRON (8MG)ORALTABLET, ORALLY DISINTEGRATINGTrueAB1999-01-27ZOFRAN ODT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5955488 (view patent)2015-11-14NDA020781Ondansetron Oral Tablet
2p6063802 (view patent)2015-11-14NDA020781Ondansetron Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10934b7ad-41c4-418d-86e3-a2ea4e7bb4c7 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-09-221216950380
20defd6c7-c493-4230-9e09-cc3784e480e2 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionRemedyrepack Inc.2013-08-211521250569
30e62c438-359f-4cec-a785-9c7ac09fa6f8 (view SPL)Ondansetron Orally Disintegrating Tablets, USPRx onlyprescriptionHuman PrescriptionRxchange Co.repack2014-12-022333580512
410641ef4-0fc9-4b24-9e43-7d06404989bb (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101521250268
514752e63-c7a7-4400-825b-ddab1ab9e782 (view SPL)ONDANSETRONprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-05-044619190218
616ed3ca8-c85c-4d06-9c4f-d5bbf344b12e (view SPL)prescriptionHuman PrescriptionHhs/Program Support Center/Supply Service CenterRELABEL, REPACK2012-02-291118190365
7192fb07a-e8b0-4f91-9882-6d456377cc98 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionRemedyrepack Inc.2014-10-141521250569
81eb89f6e-6e01-5812-e054-00144ff88e88 (view SPL)Ondansetron Orally Disintegrating Tablets, USP Rx onlyprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-09-011458650563
91edf01f7-8cc1-6616-e054-00144ff88e88 (view SPL)Ondansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral useprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-09-031458650598
10267abdd4-02f8-c04d-d009-d838f7e0a905 (view SPL)Ondansetron Hydrochloride TabletsprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2007-06-251636294014
1126aff90c-49ea-46ac-bbf3-c188c2b061c9 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2015-05-052551544567
1228e95ab0-1a7f-40dd-af0e-e54378ca06f6 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-11-141581186666
132e6db6ab-02c1-434c-b996-e8821ba03beb (view SPL)Ondansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral useprescriptionHuman PrescriptionCardinal HealthREPACK2015-03-193551543683
14340f1a87-0bc6-46bf-8f16-80a5348ad15f (view SPL)Ondansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral useprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-04-293687889329, 687889770
15366b4f74-02aa-4f67-a7cb-7362e60e1052 (view SPL)Ondansetron Tablets USPOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-211332610747, 332610761
1636c80e18-671c-4612-a8e7-07962bb102e0 (view SPL)Ondansetron Tablets USPOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-11-083682587068
17384a5cfb-05dd-2b79-73f4-a01a47a9eb3e (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-284636294306
183c34ca82-9705-4784-be7c-8b50351d14fc (view SPL)Ondansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral useprescriptionHuman PrescriptionCardinal HealthREPACK2015-09-173551543680
19482162fc-1ea6-4012-ae59-76911a047821 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-07-103925353560678
204b6ef4cb-4993-494a-bf52-901e545d1a81 (view SPL)Ondansetron Orally Disintegrating Tablets, USP Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-04-292687889670
2152dc6871-47d3-11dc-99cc-f742b487c00e (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionSun Pharmaceutical Industries LimitedANALYSIS, MANUFACTURE2015-05-055627560240, 627560356
2254d91a9e-44d8-4201-a82d-fe948a766808 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-10-161687888937
235c767c0e-9cac-4286-ab93-dece45f146ce (view SPL)Ondansetron Tablets USP, for oral useOndansetron Orally Disintegrating Tablets USP, for oral useprescriptionHuman PrescriptionRemedyrepack Inc.2014-11-041521250568
245e2dbda9-aceb-4bfb-9c3f-e7b6118f580c (view SPL)insertprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-271165900545
255fad6aba-321a-4ed3-8d8e-2806aaeb2ff7 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionSandoz Inc2014-12-0412007815238, 007815239
2663aabd84-6767-470b-bfe1-077dee835897 (view SPL)Ondansetron Orally Disintegrating Tablets, USPRx onlyprescriptionHuman PrescriptionSt Marys Medical Park PharmacyMANUFACTURE, relabel, repack2014-05-264607600305
2763bfdd45-a09a-49c6-8776-10b64e0b2430 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-02-261617860191
2869017f9f-1815-46d2-8e40-71cad10fa9d1 (view SPL)PRESCRIBING INFORMATION ONDANSETRON ORALLY DISINTEGRATING TABLETS, USPRx onlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.api manufacture, manufacture, pack2014-01-063633040346, 633040347
296a49ae10-f64d-4297-b82a-99642b583f93 (view SPL)Ondansetron Orally Disintegrating Tablets, USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-01-121617860095
306c085fdb-1e64-427d-9c01-5933de94a320 (view SPL)Ondansetron Tablets USPOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-241521250568
316c450150-a7a4-46f3-b62a-848eeefada06 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-271422540077, 422540097
32794a1ebe-399c-4ecb-94c0-507b6cc59b5d (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionRemedyrepack Inc.2015-08-251521250268
337eed9b3a-207f-49ca-83cd-8172357363d3 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-08-137551545431
3481366c85-c6c9-4a9a-9fe5-cdd8c2d19f74 (view SPL)Ondansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral useprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-012631870199, 631870256
358d763a30-c778-4560-82a0-91e7b99c8e85 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionUnit Dose ServicesREPACK2010-01-062504360133
3691eddc2b-50d6-4f5b-8916-62525fbdc375 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-08-203999353560755
379569dacb-b54d-4955-a43f-8fec30c777c4 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-12-0414430630560
389a503ba6-1a63-4059-ace3-40244d43c8f7 (view SPL)Ondansetron Tablets USPOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-03-241521250568
39a02eae38-c045-40bb-a5b2-4813165f6a09 (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-12-0413430630592
40a1f0a439-c5f3-4025-8637-a957eab4d2db (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-231521250569
41a4d7f7d0-b073-463a-83af-9587ac10c943 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-08-113581180240, 581180356
42a67eaa4d-7aa4-4a55-9198-62a51261c2ef (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-01-062430630052
43a9fdc04a-b4e5-4eed-be1f-8a629dc447be (view SPL)Ondansetron Tablets USPOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-04-251422540213
44aa5cd244-dbd5-4cd6-a9f6-e045405ae519 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-10-064003787732, 003787734
45aba318b2-e2b8-4fae-a58d-ac0b25552195 (view SPL)Ondansetron Orally Disintegrating Tablets, USPRx onlyprescriptionHuman PrescriptionRxchange Co.repack2014-12-022333580498
46b38feff2-900a-4e0c-8260-8f090edbc0bc (view SPL)ONDANSETRONprescriptionHuman PrescriptionDirect Rxrelabel2015-11-132619190986
47b9abd5ce-6aca-4fda-8f46-0bb5b7fdd5da (view SPL)Ondansetron Orally Disintegrating Tablets, USP Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-04-292687889559
48bb535ce1-0b32-449f-8093-789f9d83b96a (view SPL)Ondansetron Orally Disintegrating Tablets, USPRx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2014-11-131617860095
49bd365c0e-7f76-4904-8f21-bed9ec2d0360 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-01-063552890559
50bf2b41aa-8bac-4de7-98b2-884cbcee6c6c (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-304631870002, 631870483
51c286dba1-e6b1-4cf0-936d-9af42d8eedc3 (view SPL)Ondansetron Tablets USPOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-05-081422540212
52c7d61d98-fe86-4340-9b86-47eb92acaa0e (view SPL)ZOFRAN (ondansetron hydrochloride) Tablets ZOFRAN ODT (ondansetron) Orally Disintegrating Tablets ZOFRAN (ondansetron hydrochloride) Oral SolutionprescriptionHuman PrescriptionGlaxosmithkline Llc2014-10-0115001730569, 001730570, 001730446, 001730447, 001730489Ondansetron Oral Tablet
Ondansetron Oral Solution
53c8e90bca-6ef8-4177-810c-927c0abd32e4 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-061521250268
54ca09dd2c-02ed-4d26-af3c-aaff4120887e (view SPL)Ondansetron Orally Disintegrating Tablets, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-08-202548685749, 548685887
55cab63f24-8728-4927-aba5-53e8d2e44cdb (view SPL)Ondansetron Orally Disintegrating Tablets, USPRx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-199658620390, 658620391
56d117de5f-64e5-464c-b782-de0f07e66c8e (view SPL)Ondansetron Hydrochloride TabletsOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-273430630273
57d4868404-0515-447b-8b01-81c0478de28c (view SPL)ONDANSETRONprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-04-155619190545
58d497e5be-846f-498c-ba52-b58fffa08b20 (view SPL)Ondansetron 4 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, relabel2010-11-10456353560197
59dfa2dfa8-26b2-4623-8dab-af9e9f32320f (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-01-062430630247
60e5950fac-27c8-49b8-81d5-046ec065621b (view SPL)Ondansetron Tablets USPOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-101521250568
61e5e8353f-4e4c-4036-9376-2ac205d13b14 (view SPL)Ondansetron Tablets USPOndansetron Orally Disintegrating Tablets USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-10-051550453848
62eb74425c-c635-4d99-8e98-e63e7359fb89 (view SPL)Ondansetron Orally Disintegrating Tablets, USPRx onlyprescriptionHuman PrescriptionCitron Pharma Llc2015-05-293572370077, 572370078
63ed1132ec-c2cd-4646-b69d-26663bb937a4 (view SPL)Ondansetron Tablets USP, for oral use Ondansetron Orally Disintegrating Tablets USP, for oral useprescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, MANUFACTURE2015-07-155680010246, 680010247
64eee5217a-eba8-463a-812d-bf3c66f0934f (view SPL)Ondansetron Tablets USP, for oral useOndansetron Orally Disintegrating Tablets USP, for oral useprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, MANUFACTURE2014-11-179684620157, 684620158, 684620105, 684620106, 684620107Ondansetron Oral Tablet
65f1191e52-982e-49d1-946e-01b469ccedfe (view SPL)Ondansetron Orally Disintegrating Tablets, USP Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870266
66f3483b32-344c-4097-bd2b-56545edd0ce5 (view SPL)Ondansetron Orally Disintegrating TabletsprescriptionHuman PrescriptionRemedyrepack Inc.2014-10-291521250569
67f6f2e4ee-dc8b-478d-b0d6-d192119691b7 (view SPL)Ondansetron Orally Disintegrating Tablets, USPRx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870526
68ff8d38d7-3f94-4f4c-89ec-58265add8437 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-12-193493490858

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII